Agenda for SPL Generic Sub Team Meeting January 13, 2009
Meeting minutes from 12/15/08 – are posted on the Wiki site – any questions, additions, etc?
Meeting minutes were accepted and there were no questions.
Reminder - beginning in January we will meet every 4th Tuesday.
Nothing to add
Tom Marsden, Ryan Paul & Julie Newman/D&B presentation & Q&A session.
If you are not an existing D&B customer you can contact Julie Newman to set up an account for SPL DUNS#s only. Julie Newman �1637�703.807.5091 Tom Marsden,Julie Newman, and Ryan Paul were on the teleconference.Dun And Bradstreet is still working on a solution to get the D-U-N-S numbers out.D&B is working with vendors as well as up-staffing for this. When we contact D&B, they would like to update their information about the company that is contacting them.This will help keep the information current. Remember the D-U-N-S numbers is being used as part of the information to validate the SPL submission. Ryan PaulPaulR@DNB.com Julie NewmanNewmanJu@DNB.com Tom MarsdenMarsdenT@DNB.com Regarding costs – these are still not determined.For D-U-N-S numbers inside the corporate family tree, these numbers are not charged for.External one are charged for but the price points are not fully determined. Again, there are three methods of getting trading partner information: 1)However it has been done in the past 2)Contact the above 3 at D&B 3)Go to the vendors who are supplying this information D&B will be at the Face-to-Face meeting in May. The SPL group still needs
the cost structure
a definition of corporate family tree
speed of response and turn-around of request
for trading partner information that exists
for trading partner information that has to be generated
a quick way to find who in the sponsor company is responsible for the D-U-N-S numbers; whether it is a purchasing, legal or other department
FDA Training webinars and F2F meeting May 21, 2009.SPL Vendor training webinar 02/04/09.
Prototype stylesheets from SPL R3 & R4.
OTC vendor webinars – we will keep you informed.
Please see the Wiki for presenters, dates and times.Also there are copies of the presentations on the Wiki at: http://spl-work-group.wikispaces.com/OTC at the Vendor Presentations sub-head.
Companies registered electronically will now have their DUNS numbers on the site.
Questionnaire on Wiki site – Jeffery Karp.(PDF of Survey attached.)
The PDF of the survey is on the Wiki on the Generics page. Jeffery Karp described the survey and how to use it. Note: Post the meeting, a note was sent out inviting you to take the survey.Please do this and let us know your information and any comments you have on the survey.
January 13, 2009
- Meeting minutes from 12/15/08 – are posted on the Wiki site – any questions, additions, etc?
Meeting minutes were accepted and there were no questions.- Reminder - beginning in January we will meet every 4th Tuesday.
Nothing to add- Tom Marsden, Ryan Paul & Julie Newman/D&B presentation & Q&A session.
If you are not an existing D&B customer you can contact Julie Newman to set up an account for SPL DUNS#s only.Julie Newman
�1637�703.807.5091
Tom Marsden, Julie Newman, and Ryan Paul were on the teleconference. Dun And Bradstreet is still working on a solution to get the D-U-N-S numbers out. D&B is working with vendors as well as up-staffing for this.
When we contact D&B, they would like to update their information about the company that is contacting them. This will help keep the information current.
Remember the D-U-N-S numbers is being used as part of the information to validate the SPL submission.
Ryan Paul PaulR@DNB.com
Julie Newman NewmanJu@DNB.com
Tom Marsden MarsdenT@DNB.com
Regarding costs – these are still not determined. For D-U-N-S numbers inside the corporate family tree, these numbers are not charged for. External one are charged for but the price points are not fully determined.
Again, there are three methods of getting trading partner information:
1) However it has been done in the past
2) Contact the above 3 at D&B
3) Go to the vendors who are supplying this information
D&B will be at the Face-to-Face meeting in May.
The SPL group still needs
Many other questions were asked. Most of these should be in the FAQ. See:
http://spl-work-group.wikispaces.com/DUNS+Number+FAQ
4. Please note: One item from the Leadership team meeting is that the FDA is recommending that each company which does not have a gateway account already should obtain one ASAP.
Link here: http://spl-work-group.wikispaces.com/Electronic+Submission+Gateway+%28ESG%29
Do it!!!
- OTC vendor webinars – we will keep you informed.
Please see the Wiki for presenters, dates and times. Also there are copies of the presentations on the Wiki at:http://spl-work-group.wikispaces.com/OTC
at the Vendor Presentations sub-head.
- Questionnaire on Wiki site – Jeffery Karp. (PDF of Survey attached.)
The PDF of the survey is on the Wiki on the Generics page. Jeffery Karp described the survey and how to use it.Note: Post the meeting, a note was sent out inviting you to take the survey. Please do this and let us know your information and any comments you have on the survey.
Generic Sub Team Attendees
For meeting 1/13/09
Generic Sub Team Leader
Generics Sub Team Co Leader
Additions to the meeting:
Jeff Poisson – jpoisson@i4i.com
Marueen Kapustnski – maureen.kapustnski@cs-americas.com
Juris Lazdinis – juris.lazdins@novartis.com
Howard Shatz – hshatz@dclab.com
Theresa Gerardi – theresa.gerardi@barrlabs.com
Nicholas Romano – Nicholas.romano@novartis.com
3 from D& B:
Ryan Paul PaulR@DNB.com
Julie Newman NewmanJu@DNB.com
Tom Marsden MarsdenT@DNB.com